Spinal Fusion Implant Cross Connectors Recalled for Insufficient Clamping Force
Aesculap is recalling its S4 Cervical Cross Connector used in spinal fusion surgery due to insufficient clamping force that may cause the connectors to move on the rods or shed particles.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a high-risk spinal implant with potential for mechanical failure and particulate shedding. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported are scored as High (3).
Plain-English summary
Aesculap Implant Systems LLC is recalling the AESCULAP S4 Cervical Cross Connector L22mm (product code SW112T). This is a medical implant used to stabilize the spine during cervical fusion surgery.
The company is recalling the product because the cross connectors may have insufficient clamping force. This deficiency may cause the connectors to move on the rods during or after surgery, or may result in microparticle abrasion as the components shift.
The affected implants were distributed nationwide in California, Colorado, Illinois, Indiana, Michigan, North Carolina, Nevada, Ohio, Pennsylvania, South Carolina, Texas, and Wyoming. Approximately 24 units are affected (UDI-DI: 04038653362295).
If you have received or implanted this device, contact Aesculap Implant Systems LLC or the FDA with any questions or to report any adverse events related to this implant.
The recalled product
- Product
- AESCULAP S4 Cervical Cross Connector L22mm, S4C CROSS CONNECTOR FIXED 22MM, product code SW112T. Used in spinal fusion surgery.
- Manufacturer
- Aesculap Implant Systems LLC
- Category
- Medical Device — Spinal Implant
- Affected units
- 24
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 04038653362295
Distribution
Part of a larger recall action
This product is one of 6 recalled by Aesculap Implant Systems LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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